MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin

Boehringer Ingelheim360 enrolled

Overview

Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

360

Conditions

Diabetes Mellitus, Type 2

Interventions

PlaceboDRUG

Linagliptin 5mgDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis of type 2 diabetes mellitus * Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive) * Current therapy with ACEi or ARB at stable dose for 10 weeks * Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening. * Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min. * Age between 18 and 80 years. Exclusion criteria: * Dual or triple blockade of the Renin Angiotensin System (RAS) * Uncontrolled hyperglycaemia * Mean arterial blood pressure \> 110 mmHg * Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos). * Treatment with a glitazone within 6 months prior to informed consent. * Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent. * Treatment with anti-obesity drugs 10 weeks prior to informed consent. * Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator. * Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. * Participation in another trial with an investigational drug within 2 months prior to informed consent.

Locations (74)

Outcomes

Primary Outcomes

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment

Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double- blind trial medication. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest.

Time frame: Baseline and 24 weeks

Secondary Outcomes

The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment

The time weighted average of percentage change from baseline in UACR (mg/g creatinine) during the course of 24 weeks of treatment. The term "baseline" for UACR refers to the geometric mean of UACR values measured at Visits 2 and 3. The number of participants analysed displays the number of participants with available data at the timepoint of interest. The Least Squares Means are adjusted geometric means.

Time frame: Baseline and 24 weeks

The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment

The change from baseline in estimated glomerular filtration rate (eGFR) as assessed by chronic kidney disease epidemiology collaboration (CKD-EPI) equation (cystatin C) after 24 weeks of treatment. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest. This outcome measure is a secondary safety endpoint.

Time frame: Baseline and 24 weeks

Data from ClinicalTrials.gov

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